Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Etopophos
Etoposide phosphate 119.3mg equivalent to etoposide 100mg
Powder for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Oncology GmbH, Halle-Kunsebeck Westfalen, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Etopophos
Etoposide phosphate 579.4mg equivalent to etoposide 500mg
Powder for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Oncology GmbH, Halle-Kunsebeck Westfalen, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiamet
Empagliflozin 5mg
Metformin hydrochloride 500mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiamet
Empagliflozin 5mg
Metformin hydrochloride 850mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiamet
Empagliflozin 5mg
Metformin hydrochloride 1000mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiamet
Empagliflozin 12.5mg
Metformin hydrochloride 500mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiamet
Empagliflozin 12.5mg
Metformin hydrochloride 850mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiamet
Empagliflozin 12.5mg
Metformin hydrochloride 1000mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiance
Empagliflozin 10mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiance
Empagliflozin 25mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiancemet
Empagliflozin 5mg
Metformin hydrochloride 500mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiancemet
Empagliflozin 5mg
Metformin hydrochloride 850mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiancemet
Empagliflozin 5mg
Metformin hydrochloride 1000mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiancemet
Empagliflozin 12.5mg
Metformin hydrochloride 500mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiancemet
Empagliflozin 12.5mg
Metformin hydrochloride 850mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiancemet
Empagliflozin 12.5mg
Metformin hydrochloride 1000mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

NovoEight
Turoctocog alfa 250IU
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Gentofte, Denmark

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

NovoEight
Turoctocog alfa 500IU
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Gentofte, Denmark

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

NovoEight
Turoctocog alfa 1000IU
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Gentofte, Denmark

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

NovoEight
Turoctocog alfa 1500IU
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Gentofte, Denmark

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

NovoEight
Turoctocog alfa 2000IU
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Gentofte, Denmark

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

NovoEight
Turoctocog alfa 3000IU
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Gentofte, Denmark

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Xalkori
Crizotinib 200mg
Capsule
Pfizer New Zealand Limited
Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Xalkori
Crizotinib 250mg
Capsule
Pfizer New Zealand Limited
Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Dated this 6th day of October 2017.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).